UK Responsible Person Services

The UK has left the European Union with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for their medical devices, Mosaic Surgical offer a UK Responsible Person service, that allows us to register your products with the MHRA (MHRA Account no. 11356) on your behalf.

Mosaic Surgical understand that it is vitally important that non-UK based companies retain access to the UK market. We have made the necessary arrangements to align with stated requests from the MHRA.

The amended UK Medical Devices Regulations 2002 (SI 2002 No 618) (UK MDR 2002) which governs medical devices in the UK, will include these extra registration requirements.Our UK responsible Person Scheme is headed by our Medical Device Expert, Head of RA Rianne Mahanta. We have long experience in the field of regulations regarding medical devices and are at the forefront of regulatory compliance post-Brexit.

• • Access to individuals with expert knowledge in regulatory compliance.
  • Registration using Mosaic Surgical as your responsible person.
  • Vigilance tracking and reporting including communication with relevant interested parties.
  • Maintaining document files for questions arising from the MHRA.
  • General regulatory correspondence in the UK as required.

This service conforms fully with the requirements of the MHRA guidance.

Overview

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

This guidance provides information on the UK system, including for:

• getting your device certified
• conformity marking your device
• registering your device with the MHRA

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.

Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.

In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices.

This guidance only applies to medical devices and does not cover other CE or UKCA marked products, which are subject to separate guidance.

This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

Summary of key requirements for placing a device on the Great Britain market

Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:

• a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market
• all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market
• if you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration. Further detail on the UK Responsible Person is set out below
• CE marking will continue to be recognised in Great Britain until 30 June 2023
• certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
• the EU no longer recognises UK Notified Bodies
• UK Notified Bodies are not able to issue CE certificates – and have become UK Approved Bodies

Importers and distributors

In cases where the Great Britain importer is not the UK Responsible Person, the importer is required to inform the relevant manufacturer or UK Responsible Person of their intention to import a device. In such cases, the manufacturer or the manufacturer’s UK Responsible Person is required to provide the MHRA with details of device importers. Further guidance on device registrations.

Obligations around storage, transportation and checking device labels for the CE marking or UKCA marking also apply. The importer or distributor’s name and address do not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person for the purposes of the UKCA marking.

UKCA mark and Conformity Assessment Bodies

UKCA marking

The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland). The UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE marking for sale in these markets.

Manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the GB market until 30 June 2023. From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market.

Where third party conformity assessment is required, a UK Approved Body is needed. However, manufacturers of non-sterile and non-measuring Class I devices and general IVDs can self-certify against the UKCA marking.

See the guidance Using the UKCA mark for further information.

UKCA marking requirements are based on the requirements of the relevant Annexes to the Directives listed below, which have been modified by Schedule 2A to the UK MDR 2002:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)